Statement from FDA Commissioner Scott Gottlieb, M.D., on the process FDA is undertaking for reviewing and modernizing the agency’s standards of identity for dairy products

For Immediate Release

July 26, 2018

Statement

Improvements in diet and nutrition offer one of the greatest opportunities to profoundly impact human health. Innovation in the food sector is occurring rapidly to address this opportunity and meet the needs and values of modern consumers. The FDA is committed to advancing policies that enable consumers to safely benefit from innovations in how foods are produced.

I outlined these goals, and some of the ways we seek to achieve them, in our Nutrition Innovation Strategy. Keeping pace with the rapid innovation that has the potential to improve the choice consumers have, and the nutritional attributes of the foods they consume, is core to this commitment. So is empowering consumers with the information they need to make good choices about the foods they eat through greater transparency about food attributes.

Food labels – including the name of food – inform consumers about what they’re buying, and standards of identity are used to ensure that foods have the characteristics expected by consumers. The information provided through food labeling must be truthful and not misleading. The consumer choices made based on this information can have important impacts on health.

At the same time, the FDA is also taking actions to facilitate food innovations that can give consumers more choices, enable better nutrition, and improve labeling to reflect the healthy attributes of food. Diet is a powerful tool for reducing chronic disease and its impact on the healthcare system. Among other new steps we’re taking, modernizing the outdated framework for food standards will allow industry flexibility for innovation to produce more healthful foods while maintaining the basic nature, essential characteristics and nutritional integrity of key food products.

One area that needs greater clarity – and which has been the subject of much discussion of late – is the wide variety of plant-based foods that are being positioned in the marketplace as substitutes for standardized dairy products. Many of these plant-based foods use traditional dairy terms (e.g., milk, yogurt, cheese) in the name of the product. For instance, we’ve seen a proliferation of products made from soy, almond or rice calling themselves milk. However, these alternative products are not the food that has been standardized under the name “milk” and which has been known to the American public as “milk” long before the 1938 Federal Food, Drug, and Cosmetic Act (FD&C Act) was established. In addition, some of these products can vary widely in their nutritional content – for instance in relation to inherent protein or in added vitamin content – when compared to traditional milk.

We intend to look at these differences in relation to potential public health consequences. There are reports that indicate this issue needs examination. For example, case reports show that feeding rice-based beverages to young children resulted in a disease called kwashiorkor, a form of severe protein malnutrition. There has also been a case report of a toddler being diagnosed with rickets, a disease caused by vitamin D deficiency, after parents used a soy-based alternative to cow’s milk. Because these dairy alternative products are often popularly referred to as ‘‘milk,’’ we intend to look at whether parents may erroneously assume that plant-based beverages’ nutritional contents are similar to those of cow’s milk, despite the fact that some of these products contain only a fraction of the protein or other nutrients found in cow’s milk.

We hope that the examination of this issue will demonstrate whether future cases of kwashiorkor or rickets may be prevented by changes to the labeling of these products, as well as by the education of physicians and parents about the nutritional content of these beverages. Such public health concerns are one of the reasons why we’re prioritizing this effort to take a closer look at the standards of identity for dairy products as part of our overall process for modernizing our standards of identity and advancing the information consumers have to inform their diets.

We will not be doing this in a vacuum. We’re going to have an active public process for reviewing our standard and how consumers understand the use of terms like milk on both animal-derived and plant-based products. We want to see if the nutritional characteristics and other differences between these products are well-understood by consumers when making dietary choices for themselves and their families. We must better understand if consumers are being misled as a result of the way the term milk is being applied and making less informed choices as a result.

We also are actively looking at how we have been enforcing the FD&C Act with respect to food names and our own standard of identity for milk and what it means when milk is qualified with words like almond or soy. We recognize that, as a regulatory agency, it’s not appropriate to unilaterally change our regulatory approach if we have a history of non-enforcement. We also need to closely consider the potential First Amendment issues related to the different uses of these terms.

This week we will start the process of modernizing our standards of identity broadly by gathering stakeholder feedback at our Nutrition Innovation Strategy Public Meeting. We encourage all interested stakeholders to continue to submit comments to the docket for this meeting. We’ll be reviewing the information gathered and posting an additional request for information, likely in the late summer or early fall, with a specific set of questions pertaining to consumer awareness and understanding of the use of milk and other dairy terms on plant-based alternatives, with a focus on nutritional impact. The feedback we receive will help inform a revisiting of our policy for these terms. Over the next year, we will be looking at next steps which will likely include issuing guidance for industry and a new compliance policy outlining our enforcement approach.

In the meantime, we’ll continue to take actions when we become aware of products with misleading labels that have a high likelihood of consumer misunderstanding as to the basic nature of the product, especially when nutrition and therefore public health may be at risk.

While dairy has received a lot of attention, there are many other standards of identity that need to be revisited and potentially modernized. After all, there are nearly 300 of these standards of identity on our books, some of which were created in my grandparents’ generation.

We want to hear feedback on how the FDA should assess whether a standard of identity reflects consumer expectations about that food. We also want to hear about changes in food technology, nutritional science, fortification practices and marketing trends that we should be aware of when reviewing and updating these standards. We’ve heard concerns that these standards of identity can sometimes cause industry to avoid reformulating products to reduce things like fat or sodium content because of the limitations of these standards, so we want to hear about how modifications in our standards can facilitate the production of more healthful foods. We want to gather input from a wide range of stakeholders, and we encourage out-of-the-box ideas.

Consumers are more interested than ever before to learn about the food they eat and to use this information to make healthful choices. At the same time, we see a market that’s rapidly responding to new consumer expectations and trends. At the FDA, we have a unique chance to empower individuals who are using nutrition to improve their health and the health of their families, and to leverage diet and nutrition as a tool for impacting the burden caused by chronic disease and for reducing health inequality. Driven by our public health mission, that starts with using our tools and authorities to create better ways of communicating information to consumers about the products they’re purchasing, including nutrition information. And we’ll continue to look for new ways to promote industry innovation and provide flexibility to encourage food manufacturers to produce products with more healthful attributes. We intend to apply this science-based, public-health driven approach to the work we’re doing in relation to dairy alternatives. And we look forward to keeping you updated throughout this process.

The U.S. Food and Drug Administration, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.